Impact of Starch Digestibility on Glycemic Variability and Control, Cardiometabolic and Inflammatory Profiles, Microbiota and Intestinal Health in Subjects With Insulin Resistance

NCT07408479 | Recruiting

• 1 other identifier: KBE072 / Glymicare
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To study the potential impact of a diet rich in both Slowly Digestible Starch (SDS) and Resistant Starch (RS), we propose a 2-month nutritional intervention study in which we will study the evolution of carbohydrate variability and metabolism and health-related parameters in 40 volunteers with insulin resistance. Regular sampling of blood, urine and faeces as well as continuous measurement of blood glucose levels will be performed to assess changes in blood glucose levels, insulin resistance, lipid metabolism, inflammation and the composition of the microbiota following the introduction of starch products rich in SDS and RS into the diet.

Conditions

Insulin Resistance

Keywords

Slowly Digestible Starch; SDS; Resistant Starch; Insulin resistant subjets; Glycemic control; Continuous Glucose Monitoring System; CGMS; Diet; Mean Amplitude of Glucose Excursion; microbiota

Outcome Measures

Primary Outcomes (1)

• Change in MAGE measured on 3 occasions between diets High or Low in SDS and RS

  Mean Amplitude of Glucose Excursions (MAGE) from CGMS record

  Evaluations done before, after 1 week and after 2 months on a diet

Secondary Outcomes (57)

• Glycemia iAUC after a standard challenge test (FlexMeal) during the first metabolic day

  5 hours post standard challenge test during visit 2 (before starting nutritional intervention)

• Insulin iAUC after a standard challenge test (FlexMeal) during the first metabolic day

  5 hours post standard challenge test during visit 2 (before starting nutritional intervention)

• GLP-1 iAUC after a standard challenge test (FlexMeal) during the first metabolic day

  5 hours post standard challenge test during visit 2 (before starting nutritional intervention)

• Inflammatory status comparison during the first metabolic day : CRP concentration

  At baseline during V2 (before starting nutritional intervention)

• Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : TNFa iAUC

  5 hours post challenge test during visit 2 (before starting nutritional intervention)

Study Arms (2)

High SDS-RS diet

ACTIVE COMPARATOR

Balanced diet containing high levels of Slowly digestible Starch (SDS) and Resistant Starch (RS)

Other: Balanced diet high in Slowly Digestible Starch and Resistant Starch

Low SDS-RS diet

PLACEBO COMPARATOR

Balanced diet containing low levels of Slowly digestible Starch (SDS) and Resistant Starch (RS)

Other: Balanced diet low in Slowly Digestible Starch and Resistant Starch

Interventions

Balanced diet high in Slowly Digestible Starch and Resistant Starch OTHER

Diet where all the starchy foods were selected based on their SDS and RS content. This diet needs to be easy to apply by subjects. It will be consumed during 2 months

Also known as: Diet A, H-SDS-RS

High SDS-RS diet

Balanced diet low in Slowly Digestible Starch and Resistant Starch OTHER

Diet where all the starchy foods were selected based on their SDS and RS content. This diet needs to be easy to apply by subjects. It will be consumed during 2 months

Also known as: Diet B, L-SDS-RS

Low SDS-RS diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General criteria:
• Age between 18 and 75 years (bounds included)
• HOMA-IR ≥ 2.5
• Body Mass Index (BMI) between 25 and 40 kg/m² (bounds included)
• Stable weight over the past 3 months (+/- 5% of body weight)
• Waist circumference \> 80 cm for women, \> 94 cm for men
• Sedentary subject or subject practising regular and stable physical activity for the duration of the study (maximum 4 hours per week)
• Able to understand the provided information and having signed the informed consent forms
• Able to read and write in French
• Having a freezer and comfortable with storing stool samples at home
• Having undergone a prior medical examination during the screening visit
• Food-related criteria:
• Willing to modify their diet for 2 months
• No food intolerances or allergies
• Regular consumption of the study products

You may not qualify if:

• General criteria:
• Adult under legal protection (guardianship or curatorship)
• Person with unstable medical or psychological conditions that, according to the investigator, could lead to non-compliance or non-cooperation during the study or compromise safety or participation (as per Articles L.1121-6, L.1121-8, L.1121-9, and L.1122-1-2 of the French Public Health Code)
• Presence of a condition identified during clinical examination or medical interview that could interfere with study evaluations, as judged by the investigator
• Person deprived of liberty by judicial or administrative decision
• Person exceeding the annual compensation limit for participation in research protocols
• Tobacco (or vaping equivalent) consumption \> 5 cigarettes per day and inability to abstain from smoking or vaping from the evening prior to exploration days specified in the protocol
• Alcoholism or alcohol abuse (\> 30 g/day). Consuming more than three alcoholic drinks per day is considered abusive. One alcoholic drink corresponds to 30 mL of spirits, 120 mL of wine, or 330 mL of beer or abuse or dependency on another drug
• Person not affiliated with a social security system or benefiting from a similar scheme
• Absence of valid, approved health certificates in the event of government measures during an exceptional epidemic situation
• Biological criteria:
• Fasting blood glucose ≥ 7 mmol/L or ≥ 1.26 g/L
• Triglycerides \> 4 g/L
• LDL-cholesterol \> 1.90 g/L
• eGRF (estimated glomerular filtration rate) \< 60 ml/min

Sponsors & Collaborators

• Mondelēz International, Inc.: lead
• Centre de Recherche en Nutrition Humaine Rhone-Alpe: collaborator
• Unite MetaGenoPolis INRAE: collaborator

Study Sites (1)

Centre de Recherche en Nutrition Humaine Rhone-Alpes

Lyon, 69310, France

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Anne-Laure Castell, MD

  Centre de Recherche en Nutrition Humaine Rhône-Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie-Anne Nazare, PhD

CONTACT

+33 4 78 86 29 81; julie-anne.nazare@univ-lyon1.fr

Alexandra Meynier, PhD

CONTACT

+33 1 83 11 45 68; alexandra.meynier@mdlz.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each diet will be labelled "Diet A" or "Diet B" with both diets containing similar categories of products
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a single blind, randomized, controlled 2 months intervention study with parallel design

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 13, 2026
• Study Start: November 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)